A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

This study has been completed.

Sponsor:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT01159938

First Posted: July 12, 2010

Last Update Posted: April 3, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Participants with type 2 diabetes mellitus (T2DM) were randomized to either a high to low blood glucose sequence or a low to high blood glucose sequence dependent upon whether they received insulin lispro or not in the first study period. Participants were stratified into treatment arms based on their urinary albumin excretion rate (UAER).

Reporting Groups

Description

Healthy Participants

Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.

T2DM With Albuminuria, High to Low

T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.

T2DM With Albuminuria, Low to High

T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.

T2DM With Normal UAER, High to Low

T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.

T2DM With Normal UAER, Low to High

T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.

Participant Flow for 2 periods

Period 1: First Study Period

Healthy Participants

T2DM With Albuminuria, High to Low

T2DM With Albuminuria, Low to High

T2DM With Normal UAER, High to Low

T2DM With Normal UAER, Low to High

STARTED

26

11

11

12

12

Received at Least 1 Dose of Study Drug

0

11

11

12

12

Safety and Efficacy Analysis Population

25 [1]

11

11 [2]

12

12

COMPLETED

26

11

10

12

12

NOT COMPLETED

0

0

1

0

0

Protocol Violation (Microalbuminuria)

0

0

1

0

0

[1]

One healthy participant completed study but was excluded from analyses (major protocol violation).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All enrolled participants, with the exception of 1 healthy participant who completed the study but was later excluded from analyses due to major protocol violation.

Reporting Groups

Description

Healthy Participants

Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.

T2DM With Albuminuria

T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.

T2DM With Normal UAER

T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.